What is NDC 0597-9257?

0597-9257 is the product NDC for Hernexeos (zongertinib), Zongertinib 60 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hernexeos?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hernexeos NDC 0597-9257 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-9257Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-9257Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0597-9257-59	00597925759	1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-59) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jan 6, 2026
0597-9257-86	00597925786	1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-86) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Aug 8, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Hernexeos
Generic name (nonproprietary): zongertinib
Active ingredients: Zongertinib — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219042
Marketing start: Aug 8, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Breast Cancer Resistance Protein Inhibitors (Mechanism)HER2/Neu/cerbB2 Antagonists (Mechanism)
Identifiers: Product ID 0597-9257_0fd3e81b-38c9-4d19-b075-9256049a9d41SPL ID 0fd3e81b-38c9-4d19-b075-9256049a9d41SPL set ID d3fabf12-354e-4e5c-b5de-20fdb579b783RxCUI 2721609, 2721615UNII DRH7R67UVL
Pharmacologic class: Kinase Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400597925759 followed by a unit qualifier and the quantity

Package 00597-9257-59. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 13, 2026.

Indications (excerpt from the label)

HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0597-9257

What is NDC 0597-9257?: 0597-9257 is the product NDC for Hernexeos (zongertinib), Zongertinib 60 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hernexeos (Zongertinib).
What is the active ingredient?: Zongertinib.
Who is the labeler?: Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hernexeos?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Hernexeos (Zongertinib) NDC 0597-9257